High human cortisol is defined as cortisol levels that exceed the human population average.
In the United States, the number of women ages 15-44 with impaired fecundity (impaired ability to get pregnant or carry a baby to term) is 6.7 million. Multiple fertility clinics exist to help women with fertility issues.
Research indicates that stress is an important factor. Speculation about the correlation between stress and infertility is part of the prior art.
One fertility clinic broadcasts the following message: “The best fertility treatment is beating stress”. A 2009 study at Emory University concluded that “We think there are women who have sub-clinical forms of stress and who are infertile as a result . . . . ” More work on cortisol correlation was suggested in this Emory study. The study is informative, but does not recite a treatment method with transfer factor and lactic acid generating bacteria.
Although cortisol reduction has long been proposed as a way to enhance human fertility, no human-specific treatment method utilizing at least transfer factor and lactic acid generating bacteria has been fully enabled. Methods of treating infertility, which do not incorporate transfer factor and lactic acid generating bacteria into a fertility enhancement food, are outside the scope of the instant invention.
Cwikel et al. (European Journal of Obstetrics & Gynecology and Reproductive Biology, 117 (2004), pp. 126-131) teaches that stress levels contribute to infertility, and that cortisol levels are predictive of infertility. This study is informative. But it is outside the scope of the instant application because it does not provide a remedy based on fertility enhancement food comprising at least transfer factor and lactic acid generating bacteria.
Johnson and Everitt (“Infertility and Subfertility” in Essential Reproduction, Blackwell Science, Fifth edition, 2000; chapter 15, p. 265) connect stress and infertility issues. Cortisol is not specifically cited as a marker. And, there is no citation of a treatment method using at least transfer factor and lactic acid generating bacteria.
Stress is a broad term and carries connotations. Different observers may define stress in different symptomatic ways. Fortunately, stress is associated with a chemical marker. Cortisol is the major stress hormone, and cortisol measurement allows stress to be quantified.
The veterinary field was first to increase fertility in animals with a food-based approach. Ramaekers recites the food composition of transfer factor and lactic acid generating bacteria in U.S. Pat. No. 6,962,718. Use of the food composition to enhance livestock fertility is recited in U.S. application Ser. Nos. 13/729,923 and 13/843,581, which are currently pending. Low calving rates in cattle herds represent a large loss to a rancher. Birth rates increased when cortisol levels were intentionally lowered with a fertility enhancement food including transfer factor and lactic acid generating bacteria.
Cattle studies have repeatedly demonstrated that feeding a mixture of transfer factor and lactic acid generating bacteria increases fertility.
The experience of livestock is significant because the hormonal mechanism of stress is the same in all mammals. Humans generate the stress hormone, cortisol, in the same way as a goat, pig, cow, horse, or monkey. Basically, the pituitary releases ACTH (adrenocorticotropic hormone). Then ACTH stimulates the adrenal cortex to secrete cortisol.
Fertility improvement for humans is suggested in Ramaekers' U.S. publication 20090170774. However, optimal human treatment times and feeding frequencies were later determined to differ between humans and other mammals. These were first presented in application Ser. No. 13/999,875 by Ramaekers and Menear dated Mar. 29, 2014. This instant application focuses on method steps to optimize human fertility.
Cortisol has a positive value in the short term. It energizes the body for a fight or flight situation. But a cortisol excess over a long time is destructive. Fertility is one of the casualties.
Fertility clinics address infertility with a variety of treatments. Treatments commonly include drugs. Drug treatments may have side effects. In contrast, the mixture of transfer factor and lactic acid generating bacteria is a food, not a drug. Foods take longer to confer benefits than drugs. But, foods comprising transfer factor and lactic acid generating bacteria are inherently safe.
The consuming public now understands that foods possess more than basic nutrition (protein, carbohydrate, fat, etc.). For example, 95% of consumers agree that “certain foods have health benefits that go beyond basic nutrition and may reduce the risk of disease or other health concerns”. More than 50% of consumers believe that foods can replace the use of drugs.
The Federal Drug Administration acknowledges this trend with the relatively new category of “Medical Foods”. Medical Foods should be administered or monitored by a doctor, nutritionist, nurse, medical technician or equivalent health care professional. Medical foods are defined by the Federal Drug Administration in 21 CFR 101.9(j)(8).
A food-based fertility treatment option is needed that addresses root causes and avoids side effects. A food based treatment may be used in conjunction with other treatments.